Contraction
Conditions
Brief summary
The EUM (electrical uterine myography) (OB Tools, Israel) was tested and found to be reliable as a non-invasive method for evaluating uterine contractions and the fetal heart rate. It is safe and effective in monitoring uterine contractions. The investigators propose to perform a study to validate the accuracy and clinical usefulness of the EUM device by simultaneously monitoring obese patients with current method of external tocodynamometry with the EUM device. Providers will be blinded to the results of the EUM device. Caregivers will continue care as per current guidelines using the information obtained from the current monitoring methods. Information obtained from the EUM devices will not be used to determine the clinical course of action.
Detailed description
Purpose: The investigators propose to perform a study to validate the accuracy and clinical usefulness of the EUM device by comparing it with simultaneous use of current methods (external tocodynamometry) among obese patients. Objective: Compare the interpretability of the contractions recorded using the EUM device vs. those obtained from external tocodynamometer among obese pregnant women.
Interventions
DEVICEThe EUM300 (electrical uterine myography)
This study involves monitoring one group of pregnant women for contractions simultaneously using two different devices to determine if one is superior: the usual tocodynamometer commonly used. Women are simultaneously monitored with both devices.
Sponsors
Montefiore Medical Center
Study design
Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Maternal age \>18 years old 2. Singleton pregnancy 3. Gestational age of 24 completed weeks or greater based on the estimated due date as calculated from last menstrual period or early ultrasound 4. Category I (reassuring) fetal heart rate tracing at time of enrollment
Exclusion criteria
1. Fetal anomaly or chromosome defect 2. Allergy to silver 3. Woman with implanted electronic device of any kind 4. Irritated skin or open wound on the abdominal wall
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Continuity in Readings of Contractions | within 4 hours of device application | Continuity in readings of contractions, as measured in the number of minutes without a readable tracing in a sample tracing, between the novel EUM device and the external tocodynamometer (standard care) were assessed in pregnant preterm patients. An uninterpretable tracing was defined as any contraction, or any period of contractions, with unclear/uninterpretable baseline, peak onset/timing, height/peak, or duration of contraction. |
| Continuity in Readings of Fetal Heart Rate | within 4 hours of device application | Continuity in Fetal Heart rate readings, as measured by the number of minutes without a readable tracing in a sample tracing between the novel EUM/EMG device and the external tocodynamometer (standard care) will be assessed in pregnant preterm patients. An uninterpretable tracing is defined as any period of fetal heart rate tracing with unclear/uninterpretable baseline, variability, onset/timing, peak, frequency, or duration of accelerations/decelerations |
Countries
United States
Participant flow
Recruitment details
Prospective observational study of 48 patients at Montefiore Medical Center. Recruitment commenced following IRB approval in FEB 2017 (first patient was enrolled July 1, 2017). Study recruitment was paused due to COVID from March 2020 to June 2020 and resumed from June 2020 to May 2021.
Pre-assignment details
All 48 participants who enrolled were simultaneously monitored with the EUM Device and the typical tocodynamometer.
Participants by arm
| Arm | Count |
|---|---|
| Pregnant Women Pregnant women with singleton pregnancy with gestational age greater than or equal to 24 weeks.
The EUM300 (electrical uterine myography): External monitor intended for the evaluation of electrical signals originating in the uterus, thus providing a tool for measuring uterine activity as well as fetal heart rate. | 48 |
| Total | 48 |
Baseline characteristics
| Characteristic | Pregnant Women |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 48 Participants |
| Age, Continuous | 28.17 years STANDARD_DEVIATION 5.37 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 24 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 23 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 22 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 26 Participants |
| Race (NIH/OMB) White | 0 Participants |
| Region of Enrollment United States | 48 participants |
| Sex: Female, Male Female | 48 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 48 |
| other Total, other adverse events | 0 / 48 |
| serious Total, serious adverse events | 0 / 48 |
Outcome results
Primary
Continuity in Readings of Contractions
Continuity in readings of contractions, as measured in the number of minutes without a readable tracing in a sample tracing, between the novel EUM device and the external tocodynamometer (standard care) were assessed in pregnant preterm patients. An uninterpretable tracing was defined as any contraction, or any period of contractions, with unclear/uninterpretable baseline, peak onset/timing, height/peak, or duration of contraction.
Time frame: within 4 hours of device application
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| EUM Device | Continuity in Readings of Contractions | 0 Number of minutes | Standard Deviation 0 |
| Tocodynamometer | Continuity in Readings of Contractions | 0 Number of minutes | Standard Deviation 0 |
p-value: 0.7595% CI: [0.69, 1.31]t-test, 2 sided
Primary
Continuity in Readings of Fetal Heart Rate
Continuity in Fetal Heart rate readings, as measured by the number of minutes without a readable tracing in a sample tracing between the novel EUM/EMG device and the external tocodynamometer (standard care) will be assessed in pregnant preterm patients. An uninterpretable tracing is defined as any period of fetal heart rate tracing with unclear/uninterpretable baseline, variability, onset/timing, peak, frequency, or duration of accelerations/decelerations
Time frame: within 4 hours of device application
Population: Fetal Heart Rate data was not collected and therefore not analyzed